WASHINGTON – A first-of-its-kind medical journal study published on Sept. 24 shows that as many as 3,217 intended donations of corneas from the eyes of gay and bisexual men in 2018 that could have restored the vision of blind people through cornea transplant surgery were disqualified under an “outdated” U.S. Food and Drug Administration policy aimed at preventing HIV infection.
The study released by JAMA Ophthalmology, an American Medical Association journal, says the little-known FDA policy prohibits the donation of corneas from men who have had sex with men in the past five years from the time of the planned donation. It points out that the policy has not been revised since the FDA adopted it in 1994 despite major scientific advancements in the detection of HIV in human tissue within eight to 10 days after infection.
“With millions of people across the world in need of corneal transplants, these discarded corneas from gay and bisexual men could be used to address the shortage and safely restore vision to thousands of patients with corneal blindness or visual impairment,” said Dr. Michael A. Puente, assistant professor of ophthalmology at the University of Colorado School of Medicine and lead author of the study.
“With modern virologic testing and a better understanding of the low risk of HIV transmission through corneal transplants, this five-year deferral policy for gay men is not supported by current science,” Puente, an eye surgeon, said in a statement. “We ask federal regulators to reconsider these outdated policies which are depriving patients of the possibility of sight restoration,” he said.
Medical literature on cornea donations and corneal transplant surgery states that similar to heart transplants, corneas can only be donated by people who have died, many of whom have left an advance directive to become an organ or tissue donor.
The statement accompanying the study says all corneal donors in the United States are required to undergo three separate HIV tests. Puente told the Washington Blade the HIV tests can be performed shortly before a terminally ill person dies or shortly after death as long as at least one of the tests is performed within seven days of the time the cornea is donated.
Up until 2015, the FDA adhered to a lifetime ban on men who have sex with men, referred to as MSM, from donating blood. The FDA announced that year that a review it conducted concluded that a lifetime ban was no longer scientifically justified and recommended that MSM considering donating blood be sexually abstinent for one year. In April of this year the FDA lowered the period of abstinence for MSM blood donors to three months.
“If it’s safe for gay men to donate their blood after three months of abstinence, I can think of no scientific reason to continue to require gay men to be abstinent for five years to donate their eyes,” Puente said. “This policy can be changed without increasing the risk of HIV transmission, and I would urge authorities to act as soon as possible to help patients who are waiting for sight-restoring surgery.”
The medical journal article says to the knowledge of the teams of researchers who conducted the study, “no case of HIV transmission from a corneal transplant has been reported anywhere in the world.” The article notes that in cases where a corneal donor was discovered to be HIV positive after a transplant surgery had taken place, none of the recipients contracted HIV.
“One reason for the low transmissibility of HIV via corneal transplant is thought to be the cornea’s avascularity, which prevents the cornea from being a major reservoir of the virus,” according to the article. “Studies analyzing the corneas of HIV-infected patients have consistently found that that HIV is not present in most of the corneas of HIV-positive patients,” it reports.
The statement accompanying the study says the U.S. and Canada are “outliers” in policies restricting corneal donations for MSM. It notes that Canada currently requires MSM to have been abstinent for one year prior to a corneal donation.
“Many countries, including Spain, Italy, Mexico, Chile, and Argentina, allow gay and bisexual men to donate their eye tissue just as easily as heterosexual donors,” the statement says. “Other countries have deferral periods far shorter than five years,” says the statement. “For example, the United Kingdom allows corneal donation by gay and bisexual men after only three months of abstinence, while the Netherlands and France only require gay and bisexual corneal donors to be abstinent for four months.”
Puente told the Blade he learned that members of Congress urged the FDA to modify its MSM cornea donation policy in 2013 and the Eye Bank Association of America in 2017 also called for a change in the policy, but the FDA chose to leave the 1994 policy in place.
Monique Richards, a spokesperson for the FDA, told the Blade in an email in response to a Blade inquiry about the MSM corneal donor policy, that the current policy is based on recommendations by the U.S. Centers for Disease Control and Prevention’s 1994 guidelines published in its journal Morbidity and Mortality Weekly Report.
“Research has shown that a history of male-to-male sexual contact was associated with a 62-fold increased risk for being HIV positive, whereas the increase in risk for a history of multiple sexual partners of the opposite sex was 2.3 fold,” Richards said.
She added that the Centers for Disease Control and Prevention points out that about two-thirds of all new HIV infections in the United states occur in MSM, who make up only 2 percent of the total U.S. population.
“The FDA will continue to review its [tissue] donor deferral policies to ensure they reflect the most up-to-date scientific knowledge,” Richards said. “This process must be data-driven, so the time frame for future changes is not something we can predict.”
The JAMA Ophthalmology article can be accessed here.